The study aim is to determine the effect of applying acupressure on the severity of spinal anesthesia-induced headache in women undergoing in cesarean operation. This study is a clinical trial designs with three groups: intervention, placebo and control. The study population includes all pregnant women who candidate for cesarean with spinal anesthesia technique that admitted in Amiralmomenin’s (AS) hospital of Semnan. The main inclusion criterion is headache that induced by receiving spinal anesthesia for cesarean. The main exclusion criterion is the absence of headache between sixth until eighteenth hours after receiving spinal anesthesia for cesarean operation. The study sample size are 90 patients that were divided among three groups. Headache severity of patients will be measured by visual analogue scale (VAS) in 6 to 18 hours of post operative period. In intervention groups, acupressure will be conducted on Yintay, Taiyang, Large intestine 4, Liver 3 and GB 20 points; while, the mentioned points only will be touched without any pressure in placebo group. Also, no action will be taken in the control group. Then in three groups, the headache severity will be measured after 5 minutes. The difference between pain intensity will be calculated before and after measurements.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015071423159N2
Registration date:2015-08-09, 1394/05/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-09, 1394/05/18
Registrant information
Name
Alice Khachian
Name of organization / entity
School of Nursing and Midwifery, Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1000
Email address
khachian.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Ssciences
Expected recruitment start date
2015-05-21, 1394/02/31
Expected recruitment end date
2015-11-07, 1394/08/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure on severity of headache due to spinal anesthesia in cesarean section
Public title
The effect of acupressure on headache
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Suffering from headache after receiving spinal anesthesia; Pregnant women who have undergone elective caesarean; The lack of susceptibility to migraine or any other chronic headaches before cesarean based on patient's report; Non-suffering from seizures based on patient's report and records; Patient ability for verbal communication
Exclusion criteria: Patient intolerance for headache during intervention and demand for drugs; The nausea and vomiting or other complications in patients due to severe headache; Non- suffering from headache between six to eighteen hours after receiving spinal anesthesia
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Iran University Of Medical sience
Street address
Iran University of Medical Sciences, Hemat Highway
City
Tehran
Postal code
19922347512
Approval date
2015-05-09, 1394/02/19
Ethics committee reference number
IR.IUMS.REC.1394.26130
Health conditions studied
1
Description of health condition studied
Headache due to spinal anesthesia
ICD-10 code
o89.4
ICD-10 code description
Spinal and epidural anaesthesia-induced headache during the puerperium
Primary outcomes
1
Description
Severity of headache
Timepoint
Before and 5 minutes after intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Pain severity difference before and after intervention
Timepoint
10 minutes after intervention
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Researcher will apply pressure on Yintay between eyebrows, Taiyang at outer corner of eyes, Large Intestine 4 between thumb and index finger, Livre 3 behind feet between first and second fingers and GB 20 in first cervical vertebra in intervention group and after measuring and recording the headache intensity. The way of applying pressure on these points will be soft and deep; applying pressure on these points will be done bilateral except Yin Tai point. The pressure time on each point will be a minute. Therefore, total time of intervention will not take more than 5 minutes.
Category
Treatment - Other
2
Description
In placebo group, Yintay, Taiyang, Large Intestine 4,Liver 3 and GB 20 will be touched and no pressure will be applied.
Category
Placebo
3
Description
In control group, there will be any intervention and only headache intensity will be measured and recorded after patient suffering from headache and 5 minutes after it.